A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration

Wet Macular Degeneration Clinical Trial

Official title:

A Single Arm Open Label Study to Evaluate the Pharmacodynamics and Safety of a 4 wk Treatment With BI 144807 in Patients With Newly Diagnosed Wet Age Related Macular Degeneration (wAMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121522
• Other study ID #: 1313.20
• Secondary ID: 2013-004567-30
• Status: Completed
• Phase: Phase 2
• First received: April 22, 2014
• Last updated: May 10, 2015
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

The present trial will use an open label design to investigate the effect of BI 144807 on central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD patients. A further objective is to collect data on adverse events, vital signs, ECG and clinical laboratory parameters of BI 144807 in the same patient group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion criteria:

Newly diagnosed men and women with unilateral subfoveal choroideal neovascularization secondary to age-related macular degeneration

Exclusion criteria:

Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• BI 144807
twice daily

Locations

Country	Name	City	State
Austria	1313.20.43001 Boehringer Ingelheim Investigational Site	Wien
Germany	1313.20.49004 Boehringer Ingelheim Investigational Site	Bonn
Germany	1313.20.49002 Boehringer Ingelheim Investigational Site	Leipzig
Germany	1313.20.49001 Boehringer Ingelheim Investigational Site	Lübeck
Germany	1313.20.49005 Boehringer Ingelheim Investigational Site	Münster
Germany	1313.20.49003 Boehringer Ingelheim Investigational Site	Tübingen
Germany	1313.20.49006 Boehringer Ingelheim Investigational Site	Ulm
Hungary	1313.20.36002 Boehringer Ingelheim Investigational Site	Budapest
Hungary	1313.20.36003 Boehringer Ingelheim Investigational Site	Budapest
Hungary	1313.20.36001 Boehringer Ingelheim Investigational Site	Debrecen

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in 1mm central retinal thickness as measured by SD-OCT		Baseline and 4 weeks	No
Secondary	Change in neovascular leakage by fluorescein angiography from baseline		Baseline and 4 weeks	No